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Ensuring reliable patient access to safe and effective medicines requires every link in the supply chain to be secure: from the moment a drug leaves the manufacturer until it reaches a pharmacy or health care professional’s offices. Since 2013, the U.S. Food and Drug Administration has been implementing the Drug Supply Chain Security Act, a law known as DSCSA. This law gives the FDA more regulatory tools to detect and help ensure the removal of dangerous drugs from the supply chain, such as those that may be counterfeit, stolen, contaminated, or otherwise harmful.
Requirements of this law improve supply chain security activities by trading partners, for example, prescription drug manufacturers, repackagers, wholesale distributors, third-party logistics providers (3PLs), and dispensers, primarily pharmacies. Gradual implementation of the requirements for product tracing, product identification, authorized trading partners, and verification, is helping trading partners develop required systems for interoperable, electronic tracing of products down to the package level. Interoperable electronic systems are those that can exchange data accurately, efficiently, and consistently about each package (i.e., smallest individual saleable unit) as it is distributed in the U.S.
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